Protocol Number. 1002-048 Protocol Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180 mg/day as Add-on to Ezetimibe Therapy in Patients with Elevated LDL-C Protocol Date: 18 January 2017 Sponsor: Esperion Therapeutics, Inc. Country where Institution is Conducting Study Czech Republic Location where the study will be conducted: Kardiologická ambulance, which is a division/part of the Institution Key Enrollment Date: 100 Calendar Days after Site Initiation Visit (being the date by which Site must enrol at least one (1) subject as more specifically set out in section 1.7 “Key Enrollment Date” below) ECMT / EC / RA ECMT: Ethics Committee Fakultni nemocnice v Motole V Uvalu 84 150 06 Xxxxx 0 Xxxxx Xxxxxxxx; Mgr. xxxxxxxxxxxxx Etická komise Nemocnice Havlíčkův Brod Husova 2624 580 22 Havlíčkův Brod RA: State Institute for Drug Control, Xxxxxxxxx 00, 000 00 Xxxxx 00 Xxxxx Xxxxxxxx Investigator name, (the “Investigator”) xxxxxxxxxxxxx Číslo Protokolu: 1002-048 Název Protokolu: Randomizované, dvojitě zaslepené, placebem kontrolované multicentrické klinické hodnocení, s paralelními skupinami, posuzující účinnost a bezpečnost kyseliny bempedové (ETC 1002) 180 mg denně jako doplňku k léčbě ezetimibem u pacientů se zvýšenou hladinou LDL-C Datum Protokolu: 18. 1. 2017 Zadavatel: Esperion Therapeutics, Inc. Stát, ve kterém má sídlo Zdravotnické zařízení, které provádí Studii Česká republika Místo, kde bude prováděna Studie: Kardiologická ambulance, která je součástí/oddělením Zdravotnického zařízení Klíčové datum zařazení: 100 kalendářních dnů po Iniciační návštěvě Místa provádění klinického hodnocení (a to jakožto den, ke kterému je Místo provádění klinického hodnocení povinno zařadit minimálně jeden (1) subjekt, jak je dále podrobněji rozvedeno níže v odstavci 1.7 “Klíčové datum zařazení”) MEK / EK / SÚKL MEK: Etická komise Fakultní nemocnice v Motole V Úvalu 84 150 06 Xxxxx 0 Xxxxx xxxxxxxxx; xxxxxxxxxxxxx Etická komise Nemocnice Havlíčkův Brod Husova 2624 580 22 Havlíčkův Brod SÚKL: Státní ústav pro kontrolu léčiv, Šrobárova 48, 100 41 Xxxxx 00 Xxxxx xxxxxxxxx Jméno zkoušejícího, ( “Zkoušející”) xxxxxxxxxxxxx The following additional definitions shall apply to this Agreement: Ve Smlouvě jsou použity následující smluvní definice:
Protocol Number. IHLOSAOLE1Site: Xxxxxx Health
Protocol Number. IHLOSAOLE1Site: Xxxxxx Health Schedule 3
Examples of Protocol Number in a sentence
In addition to other necessary routing information detailed in Exhibit B, each payment shall clearly reference the: Study Protocol Number and PI name.
A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of BA058 in Healthy Postmenopausal Women ( Pending FDA Approval) Protocol Number: BA058-05-001 The study will be designed to: · Determine the safety and tolerability of multiple subcutaneous doses of BA058 in healthy postmenopausal women.
A PIP Validation Worksheet based on CMS EQR Protocol Number 1 is completed by the Technical Reviewer.
A Phase I Single-Center study in two parts assessing the safety, pharmacokinetics, pharmacodynamics and absolute bioavailability of BIM44058, a hPTHrP(1-34) analogue, administered as single doses to healthy elderly volunteers of both genders: Part A, randomized, double-blind, dose-escalating, parallel groups, placebo-controlled design; Part B, randomized, open-label, two-period, cross-over design Protocol Number: 2-52-52127-001 The strategic goals for this study are...
In addition to other necessary routing information detailed in Exhibit B, each payment shall clearly reference the Study Protocol Number and PI name.
More Definitions of Protocol Number
Protocol Number. IHLOSAPOC1Site: University of Western Australia_FINAL [***]
Protocol Number. 207499 Číslo 207499 Protocol Title: A Phase III, Multicenter, Open-Label, Randomized Název Study to Evaluate the Protokolu: Efficacy and Safety of Multicentrické, otevřené, randomizované klinické hodnocení fáze III posuzující účinnost a bezpečnost Belantamab Mafodotin in Combination with Pomalidomide and Dexamethasone (B-Pd) versus Pomalidomide plus Bortezomib and Dexamethasone (PVd) in Participants with Relapsed/Refractory Multiple Myeloma (DREAMM 8) belantamab mafodotinu v kombinaci s pmalidomidem a dexametazonem (B-Pd) v porovnání s pomalidomidem v kombinaci s bortezomibem a dexametazonem (PVd) u účastníků s relabujícím/refrakterním mnohočetným myelomem (DREAMM 8) Protocol Date: 16 April 2020 Datum Protokolu: 16. dubna 2020
Protocol Number. BUS-P3-02 (CALM-2) Číslo Protokolu: BUS-P3-02 (CALM-2)
Protocol Number. IHLOSAOLE1Site: Xxxxxx Health For use where the Indemnified Party is providing premises for the conduct of the Study and HREC Review. OR is providing premises only. To: Xxxxxx Health, ABN 27 318 956 319 a body corporate established under the Health Services Xxx 0000 (Vic) of Xxxxxxxxxx Xxxx, Xxxxxxxxx 0000 Xxxxxxxx Xxxxxxxxx or Xxxxxx Health, in which the study is to be conducted (“the Indemnified Party”) Re: Clinical Study No. [IHLOSAOLE 1]: An Open Label Extension on the Examination of the Combination of Dronabinol and Acetazolamide for Treatment of Obstructive Sleep Apnoea (OSA)
Protocol Number. IHLOSAOLE1Site: Xxxxxx Health Schedule 1 Study Name: An Open Label Extension on the Examination of the Combination of Dronabinol and Acetazolamide for Treatment of Obstructive Sleep Apnoea (OSA) Study Site/s: The Xxxxxx Hospital Target number of Study Participants: Minimum: 12 Maximum: 12
Protocol Number. IHLOSAPOC1 Site: Xxxxxx Health Protocol Number: IHLOSAPOC1 Site: Xxxxxx Health Protocol Number: IHLOSAPOC1 Site: Xxxxxx Health Protocol Number: IHLOSAPOC1 Site: Xxxxxx Health
Protocol Number. IHLOSAPOC1Site: University of Western Australia_FINAL A Setup and Study Establishment Fee, a one-time fee for the quotation, set up and establishment of the trial, upon Site Initiation Visit and payable upon receipt of an invoice. [***] Protocol Amendment Fee will be paid for the changes to pathology activities, should the protocol amendment require. This fee will be charged per amendment. [***] Specimen Phlebotomy Collection and Processing Fee will be paid, per sample for the collection, handling and processing of samples, specifically for this study. [***] Standard Full Blood Panel Fee will be charged per sample per participant, and as mandated by the participant schedule and protocol. [***] Urea and Electrolytes and Liver Function Testing Fee will be charged per sample per participant, and as mandated by the participant schedule and protocol. [***] Urine Drug Screen Fee will be charged for each drug screen performed, as mandated by the protocol [***]